BIOSTATISTICS AND BIOINFORMATICS SHARED RESOURCE PROJECT SUMMARY/ABSTRACT The Biostatistics and Bioinformatics Shared Resource (Biostats SR) is an essential asset to Case Comprehensive Cancer Center (Case CCC) members' research, illustrated by the breadth of scientific program involvement and reflected in the large number of investigators who use this SR. Last year alone over 140 investigators, 53% of whom were Case CCC members, from all 7 of the Center's Programs, used the SR on over 300 projects, for a combined 6,500 hours. The primary focus of the Biostats SR is to provide statistical support for proposal/clinical protocol development, pilot studies, or other NIH-funded peer-reviewed studies. In addition, using a standard chargeback model and collaborative grant effort model, this SR provides data analysis services including big and dense omic datasets. The Biostats SR also leverages institutional resources from the Institute for Computational Biology (ICB) to provide and strengthen informatics support. The Biostats SR brings together expertise and intellectual resources in biostatistics, bioinformatics, informatics, clinical trials, epidemiology, and statistical computing. The Biostats SR provides data analysis services using standard chargeback and collaborative grant effort models. Biostats SR biostatisticians serve on the Protocol Review and Monitoring Committee (PRMC), assisting with review of new studies and monitoring of ongoing studies. Specific aims of the Biostatistics & Bioinformatics Shared Resource are to: 1) Provide biostatistical, bioinformatics, and research informatics support to Case CCC members for design, planning, conduct, analysis, and reporting of research studies. 2) Ensure that Case CCC studies are designed, conducted, and monitored properly by reviewing protocols and proposals, and contribute to quality control and data and safety monitoring of ongoing clinical studies. 3) Provide and coordinate informatics support by using the OnCore clinical trials management database and other secure research databases, and serve as a concierge for translational informatics in the Case CCC. At last review, the Biostats SR was rated ?Outstanding Merit?. Throughout the current funding cycle (2012-2016), the Biostats SR provided services to 298 registered users, 134 (45%) of whom are Case CCC members, representing all 7 of the Case CCC programs. The value-added services (formulation of research questions and experimental design, power and sample size calculations, data quality assessment and control, statistical analysis, results interpretation, as well as proposal/manuscript writing and support) provided by the Biostats SR is demonstrated by the successful contribution of Biostats SR personnel to the Center?s research productivity. Initial collaborations supported by the Center often lead to successful new funding via collaborative research grants on which Biostats SR personnel serve as co-investigators. Biostats SR services are essential in enhancing the quality of science in the Center.